MYLAN-ATAZANAVIR CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ATAZANAVIR (ATAZANAVIR SULFATE)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

J05AE08

INN (International Name):

ATAZANAVIR

Dosage:

300MG

Pharmaceutical form:

CAPSULE

Composition:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0149741004; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-04-18

Summary of Product characteristics

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_Page 1 of 81_
PRODUCT MONOGRAPH
Pr
MYLAN-ATAZANAVIR
atazanavir sulfate capsules
150 mg, 200 mg and 300 mg atazanavir
Azapeptide Inhibitor of HIV-1 Protease
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
May 19, 2021
Submission
Control No: 251525
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_Page 2 of 81 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE
REACTIONS............................................................................................12
DRUG INTERACTIONS
............................................................................................24
DOSAGE AND ADMINISTRATION
.........................................................................40
OVERDOSAGE
.........................................................................................................42
ACTION AND CLINICAL
PHARMACOLOGY.........................................................43
STORAGE AND STABILITY
....................................................................................48
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................48
PART II: SCIENTIFIC INFORMATION
..........................................................................
50
PHARMACEUTICAL INFORMATION
.....................................................................50
CLINICAL TRIALS
...................................................................................................52
DETAILED
PHARMACOLOGY................................................................................58
MICROBIOLOGY
..........................